GB/T 18457-2024 English PDF (GBT18457-2024)

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GB/T 18457-2024: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
GB/T 18457-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
Replacing GB/T 18457-2015
Stainless steel needle tubing for the manufacture of medical
devices - Requirements and test methods
(ISO 9626:2016, MOD)
ISSUED ON: AUGUST 23, 2024
IMPLEMENTED ON: SEPTEMBER 01, 2025
Issued by: State Administration for Market Regulation;
National Standardization Administration.
Table of Contents
Foreword ... 4
1 Scope ... 7
2 Normative references ... 7
3 Terms and definitions ... 7
4 Materials ... 8
5 Requirements and test methods ... 8
5.1 General... 8
5.2 Surface roughness and appearance ... 8
5.3 Cleanliness ... 9
5.4 pH limit ... 9
5.5 Size identification ... 9
5.6 Size ... 9
5.7 Stiffness ... 11
5.8 Toughness ... 12
5.9 Corrosion resistance ... 13
Appendix A (Informative) Stainless steel designations ... 14
Appendix B (Normative) Test solution preparation method ... 16
B.1 Principle ... 16
B.2 Apparatus and reagents ... 16
B.3 Preparation procedure ... 16
Appendix C (Normative) Test method for stiffness of needle tube ... 17
C.1 Principle ... 17
C.2 Instrument ... 17
C.3 Test procedure ... 17
C.4 Test report ... 18
Appendix D (Normative) Test method for needle tube toughness ... 19
D.1 Principle ... 19
D.2 Instrument... 19
D.3 Steps ... 19
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
"Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents".
This document replaces GB/T 18457-2015 "Stainless steel needle tubing for the
manufacture of medical devices". Compared with GB/T 18457-2015, in addition to
structural adjustments and editorial changes, the main technical changes are as follows:
a) CHANGE the scope, ADD the size of 0.18 mm (34G) (see Chapter 1; Chapter 1
of the 2015 edition);
b) ADD the terms and definitions (see Chapter 3);
c) CHANGE the requirements for materials (see Chapter 4; Chapter 4 of the 2015
edition);
d) ADD the size requirements for ultra-thin walls and very thin walls of some
specifications (see Chapter 5);
e) ADD the specific size requirements for the nominal outer diameter of 0.18 mm
needle tubes (see Table 1);
f) CHANGE the requirements for size marking (see 5.5; Chapter 5 of the 2015
edition);
g) CHANGE the needle tube size and stiffness parameter table (see 5.7; Chapter 9
of the 2015 edition);
h) CHANGE the relevant requirements for the preparation method of the test
solution (see Appendix B; Appendix B of the 2015 edition);
i) DELETE the "Test method for pH of needle tubes" (see Appendix C of the 2015
edition);
j) CHANGE the test method and requirements for needle tube stiffness (see
Appendix C; Appendix D of the 2015 edition);
k) CHANGE the test method and requirements for needle tube toughness (see
Appendix D; Appendix E of the 2015 edition);
l) CHANGE the requirements for the needle tube corrosion resistance test report (see
E.4; F.4 of the 2015 edition).
This document modifies and adopts ISO 9626:2016 "Stainless steel needle tubing for
the manufacture of medical devices - Requirements and test methods".
Compared with ISO 9626:2016, this document has made the following structural
adjustments:
- DELETE 5.7 of ISO 9626:2016, the subsequent article numbers have been moved
forward;
- ADD the Appendix A;
- Appendix B corresponds to Appendix A of ISO 9626:2016;
- Appendix C corresponds to Appendix B of ISO 9626:2016;
- Appendix D corresponds to Appendix C of ISO 9626:2016;
- Appendix E corresponds to Appendix D of ISO 9626:2016;
- DELETE the Appendix E of ISO 9626:2016.
The technical differences between this document and ISO 9626:2016, as well as their
reasons, are as follows:
- CHANGE the material requirements, to meet domestic technical conditions (see
Chapter 4; Chapter 4 of ISO 9626:2016);
- DELETE the requirements of 5.7 "Sample size" in ISO 9626:2016, to avoid
ambiguity with 5.1 General;
- USE the normative reference GB/T 6682 to replace ISO 3696 (see B.2.1), to adapt
to China’s national conditions;
- CHANGE the toughness requirements, to meet domestic technical requirements
(see Appendix D; Appendix C of ISO 9626:2016).
This document has made the following editorial changes:
- DELETE the notes in Chapter 4 of ISO 9626:2016;
- ADD the "Stainless steel designations" (see Appendix A);
- DELETE the informative Appendix E of ISO 9626:2016 "Basic principles of
needle tube stiffness test method".
Please note that some contents of this document may involve patents. The issuing
agency of this document does not assume the responsibility for identifying patents.
This document was proposed by the State Food and Drug Administration.
This document shall be under the jurisdiction of the National Technical Committee for
Standardization of Medical Syringes (Needles) (SAC/TC 95).
Stainless steel needle tubing for the manufacture of medical
devices - Requirements and test methods
1 Scope
This document specifies the requirements for stainless steel needle tubes (hereinafter
referred to as needle tubes), which have designated metric sizes ranging from 0.18 mm
(34G) to 3.4 mm (10G); describes the test methods.
This document applies to rigid needle tubes for the manufacture of hypodermic needles
and other medical devices for human use.
This document does not apply to flexible needle tubes, because their mechanical
properties are different from those of rigid needle tubes specified in this document;
however, manufacturers and purchasers of flexible needle tubes are encouraged to
choose the sizes specified in this document.
Note: When the needle tube is integrated into a ready-to-use device, additional performance
tests may be required on the needle tube.
2 Normative references
The contents of the following documents constitute essential provisions of this
document through normative references in the text. Among them, for dated references,
only the version corresponding to that date applies to this document; for undated
references, the latest version (including all amendments) applies to this document.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
(GB/T 6682- 2008, ISO 3696:1987, MOD)
ISO 15510:2014 Stainless steels - Chemical composition
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Designated metric size
The outer diameter of the needle tube as defined in Table 1.
Appendix D
(Normative)
Test method for needle tube toughness
D.1 Principle
Fix one end of the needle tube; apply a force from the fixed point to the needle tube
with a specified span; first bend in one direction and then in the opposite direction to a
specified angle; repeat the bending to the specified number of cycles.
D.2 Instrument
D.2.1 Fixture and bracket for fixing the needle tube.
Note: The fixture in contact with the needle tube is made of suitable materials and structures,
to ensure that the needle tube is not damaged during the test.
D.2.2 The equipment can provide a sufficient force to the needle tube, to make the
bending angle of the needle tube meet D.3.2.
D.3 Steps
D.3.1 One end of the needle tube is firmly fixed on the fixture (D.2.1).
D.3.2 Use the device (D.2.2) to apply a force, that causes the needle tube to bend on the
plane, at a distance in Table...